According to Mylan, its subsidiary Mylan Specialty L.P. has received FDA approval for its Abbreviated New Drug Application (ANDA) for levalbuterol inhalation solution, a generic version of Sunovion’s Xopenex inhalation solution. The product is used for the treatment of bronchospasm caused by asthma and COPD. Mylan says that it has begun shipping product.
Sunovion had been awarded an $18 million judgment against Mylan after a jury found Mylan guilty of infringing on patents related to Xopenex. The two companies settled in May 2012, with Sunovion agreeing to license Mylan to sell the product and waiving the damage award.
Read the Mylan press release.
